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Virus Therapy

Gene Therapy for Lymphoma in HIV Patients

Phase 1 & 2

Waitlist Available

Led By Mehrdad Abedi

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- In partial remission

- Relapsed after initial complete remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing a new gene therapy for HIV-related lymphoma. The therapy involves inserting anti-HIV genes into the patient's stem cells in the laboratory. The goal is to make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

Who is the study for?

Adults over 18 with HIV-related lymphomas that have relapsed or didn't respond to treatment, who are now receiving a stem cell transplant. They must be on stable antiretroviral therapy, have good organ function and performance status, and agree to use contraception. Excluded are those with severe health issues like dementia, uncontrolled infections, recent heart problems, or other cancers.Check my eligibility

What is being tested?

The trial is testing gene therapy using 'anti-HIV genes' in stem cells for patients with HIV-related lymphoma undergoing stem cell transplants. The aim is to make immune cells resistant to HIV-1 infection. It includes lab analysis of biomarkers and various chemotherapy drugs alongside the transplantation procedure.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion of modified cells, effects from chemotherapy such as nausea, fatigue, hair loss and increased risk of infections due to weakened immunity. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is partially responding to treatment.

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My cancer returned after it was initially gone.

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My cancer is in remission but considered high-risk.

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My kidney function, measured by creatinine, is within normal limits.

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I am 18 years old or older.

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My cancer responded to the second round of treatment after the first failed.

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My lymphoma is confirmed by biopsy to be plasmablastic or peripheral T cell type.

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My cancer went away, came back, and is now gone again.

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My cancer has returned after a period of no signs of disease.

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I am mostly able to care for myself and carry out daily activities.

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I am on HIV medication but not taking certain drugs.

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My HIV viral load meets the trial's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Who Achieve a Timely Engraftment

Secondary outcome measures

CD4 Count Recovery

HIV-1 Viral Load

Integration Sites of Vector Sequences in Circulating Cells

+13 more

Other outcome measures

Expansion of HIV-1 Resistant Immune Cells

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (anti-HIV gene transduced CD34+ cells)Experimental Treatment8 Interventions

Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Cytarabine

2016

Completed Phase 3

~3310

Etoposide

2010

Completed Phase 3

~2440

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Carmustine

1990

Completed Phase 3

~1790

Melphalan

2008

Completed Phase 3

~1500

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,478 Total Patients Enrolled

California Institute for Regenerative Medicine (CIRM)OTHER

63 Previous Clinical Trials

3,137 Total Patients Enrolled

AIDS Malignancy ConsortiumLead Sponsor

63 Previous Clinical Trials

9,615 Total Patients Enrolled

Media Library

Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02797470 — Phase 1 & 2

HIV/AIDS Research Study Groups: Treatment (anti-HIV gene transduced CD34+ cells)

HIV/AIDS Clinical Trial 2023: Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells Highlights & Side Effects. Trial Name: NCT02797470 — Phase 1 & 2

Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02797470 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other ongoing clinical trials that use Peripheral Blood Stem Cell Transplantation?

"At this time, 535 clinical trials regarding Peripheral Blood Stem Cell Transplantation are ongoing, with 138 of those in Phase 3. Although several clinical trials for Peripheral Blood Stem Cell Transplantation originate in Seattle, Washington, there are a total of 21933 active study locations worldwide."

Answered by AI

Are there any unfilled positions in this clinical trial for willing participants?

"That is accurate, the clinicaltrials.gov website does show that this study is currently looking for volunteers. The trial was created on 6/23/2016 and updated as recently as 10/3/2022. The study needs 18 patients from 4 different locations."

Answered by AI

What blood-related disorders does Peripheral Blood Stem Cell Transplantation commonly help alleviate?

"merkel cell cancer patients often opt for Peripheral Blood Stem Cell Transplantation, which can also be used to target other forms of cancer like meningeal leukemia, prostate cancer, and small cell lung cancer (sclc)."

Answered by AI

How many people are being asked to participate in this research project?

"That is correct, according to the information available on clinicaltrials.gov this study needs more participants and is actively recruiting them. The trial was first posted on June 23rd, 2016 with the most recent update being October 3rd, 2020. In total, they are looking for 18 individuals across 4 sites."

Answered by AI

What is the main purpose of this experiment?

"The primary goal of this month-long study is to observe the efficacy of the candidate product by measuring the percentage of mononuclear blood cells expressing anti-HIV genes. Other objectives include studying vector stability, gene modified HIV-1 resistance in peripheral blood cells and gut mucosal immune cells, and CD4 count recovery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

2016. "Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02797470.

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